Contoura With Phorcides Compared to Wavefront Optimized LASIK

Myopia Clinical Trial

Official title:

Comparison of Visual Acuity and Quality of Life Following Contoura With Phorcides Compared to WaveLight Wavefront Optimized LASIK

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05486546
• Other study ID #: AMPLIO
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2023
• Source: Vance Thompson Vision
• Contact: Daniel Terveen, MD
• Phone: 605-645-7999
• Email: daniel.terveen[@]vancethompsonvision.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparing post-operative visual acuity and patient reported satisfaction between Contoura with Phorcides and WaveLight Wavefront Optimized.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 38 Years

Eligibility

Inclusion Criteria:

• Patients at least age 21 years of age undergoing LASIK eye surgery

• Willing and able to comprehend informed consent and complete 1 month post-op visit

• Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion

• Candidates for Contoura with Phorcides (Myopic, astigmatism <3.0D)

• Both eyes targeted for plano

• Pre-operative total corneal Pachymetry 490um or above

• Stable refractive error <0.50D change in preceding year

• Good general and ocular health

• Pre-operative exam completed within three months of surgery

• SCL discontinued 3 days prior to pre-op exam and the procedure

• Pachymetry above 490 with residual greater than 270um

• Candidates who, as determined by the investigator, can safely undergo LASIK

Exclusion Criteria:

• Patients under 21 years of age

• Concomitant ocular condition which would limit the BCVA at the discretion of the surgeon

• Patients with usual relative and absolute contraindications for LASIK surgery (Patients with severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes)

• Pachymetry below 490

• Autoimmune or immunodeficiency diseases

• Pregnant or nursing women

• Patients with signs of inability to understand consent for study and procedure planned

• Patients with history of previous ocular surgery

• Patients with strabismus or amblyopia

• Patients that have a BCDVA of 20/25 or worse in either eye

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Procedure:
• Contoura with Phorcides
Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine

Device:
• WaveLight Wavefront Optimized
Participants that undergo LASIK surgery using WaveLight Wavefront Optimized

Locations

Country	Name	City	State
United States	Vance Thompson Vison	Bozeman	Montana
United States	Vance Thompson Vision	Fargo	North Dakota
United States	Vance Thompson Vision	Omaha	Nebraska
United States	Vance Thompson Vision	Sioux Falls	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Daniel Terveen	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-Op UDVA	Percent of participants with monocular UDVA of 20/16 or better	3 months post-op
Secondary	Post-OP BCVA	Percent of participants with monocular and binocular BCVA of 20/16 or better	3 months post-op
Secondary	Residual Refractive Error	Residual astigmatism and residual SE	3 months post-op
Secondary	Low Contrast Visual Acuity	25% low contrast visual acuity post-op	3 months post-op
Secondary	Pre-op and post-op visual acuity	Percent of participants with post-op UDVA equal to or better than their pre-op CDVA	3 months post-op
Secondary	Corrected Distance Visual Acuity	Compare percent of participants with post-operative and pre-operative CDVA	3 months post-op